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Clinical and Histological Study of a Novel Dermal Substitute

Recruitingn/aAges 1 Year - 75 YearsAllUniversity Children's Hospital, Zurich
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In plain words

What the trial is, and whether it could suit you

The goal of this observational study is to compare a novel dermal substitute to a the current standard procedure in the treatment of full thickness skin defects. The main questions aim to answer are: • Is the skin elasticity treated with the novel dermal substitute better than the skin elasticity treated with the current standard procedure Participants skin elasticity will be measured by Cutometer® MPA-580 assessment.

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
Inclusion Criteria: * Age: 1 to 75 years * Full-thickness skin defect qualifying for coverage with the dermal substitute NovoSorb® BTM before transplantation with a STSG: * Acute cases: burn injury, soft tissue injury, skin necrosis after purpura fulminans or similar condition * Reconstructive cases (elective surgery): e.g. scar formation after burn injury, giant congenital nevus, defect after removal of skin tumor, skin defect due to other surgical procedures * Documented medical treatment decision of covering the full-thickness skin defects with either the two-step BTM/STSG procedure or with STSG alone or by using both techniques on different wound areas * Informed consent by patients/parents or other legal representative Exclusion Criteria: * Infected wounds needing surgical procedure other than a dermal template * Patients with known underlying or concomitant medical conditions that may interfere with normal wound healing (e.g. immune deficiency, systemic skin disease, any kind of congenital defect of metabolism including diabetes) * Previous enrolment of the patient into the current study * Adolescent/Adult patients or in case of children their parents/legal representatives unable to comply with the study protocol * Pregnant or breast feeding females
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What it tests

  • Standard of care
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Where

4 sites
Cantonal Hospital Aarau
Aarau, Switzerland
University Children's Hospital Zurich
Zurich, Switzerland
University Hospital Zurich
Zurich, Switzerland
Cantonal Hospital Winterthur
Winterthur, Switzerland
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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